Phase 3 N=63 Randomized Triple-blind Treatment

Enhancing Adaptations to Exercise

Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT03350906 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Change in Maximum Workload Muscle Strength — 7.5; 3.1 pounds

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: n3-PUFA (Drug); Placebo (Drug); Biopsy (Procedure); Body Composition Scan (Diagnostic_test)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Maximum Workload Muscle Strength	7.5; 3.1	—
PRIMARY Body Mass Index (BMI)	27.1; 26.3; 27.2; 26.3	—
PRIMARY Body Fat	36.9; 35.8; 36.7; 35.8	—
PRIMARY Lean Body Mass	46.0; 45.5; 46.1; 45.5	—
SECONDARY C-Reactive Protein (CRP)	1.7; 1.6; 1.5; 2.2	—
SECONDARY Erythrocyte Sedimentation Rate (ESR)	7.8; 8.8; 7.5; 10.1	—
SECONDARY Weight	77.3; 74.5; 77.1; 74.5	—

Summary

Researchers are trying to understand how chronic inflammation affects muscle function and responses to exercise.They are also trying to determine if suppressing chronic inflammation using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise responsiveness in older adults.

Eligibility Criteria

Inclusion criteria

Men and women between the ages of 20-35 years
Men and women between the ages of 65-85 years

Exclusion criteria

Regular use of omega-3 nutritional supplements
Diabetes or fasting plasma glucose > or equal to 126 mg/dL
Anemia (female subjects hemoglobin of 1.5mg/dl)
Chronic active liver disease (AST>144 IU/L or ALT>165 IU/L)
Oral warfarin group medications or history of blood clotting disorders.
international normalized ratio (INR) >2.01.5
Smoking
Pregnancy or breastfeeding
Alcohol consumption greater than 2 glasses/day or other substance abuse
Untreated or uncontrolled hypothyroidism
Debilitating chronic disease (at the discretion of the investigators)
Fish or shellfish allergy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03350906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.